MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANN, BLUNT TIP SCREW, 4X44MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ann, proximal humerus, right, long, 8.5x240mm; catalog#47249624008; lot#3026936.Ann, blunt tip screw, 4x40mm; catalog# 47248604040; lot#3068919.Ann, blunt tip screw, 4x46mm; catalog#47248604640; lot#3068905.Cortical bone screw, 4x22mm; catalog#47248612240; lot#3068948.Cortical bone screw, 4x22mm; catalog#47248612240; lot#3073758.Cortical bone screw, 4x24mm; catalog#47248612440; lot#3078178.Torque limiting handle; catalog#27923; lot#unknown.Foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00315, 0009613350-2022-00317, 0009613350-2022-00319.
Event or Problem Description
It was reported that the surgeon found that 2 of the proximal screws were backed out from the proper position approximately 1 month after the implantation.The surgeon is keeping an eye on the patient's condition and no revision is planned so far.Harm not reported.Attempts have been made and no further information has been made available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.As no product was returned, visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, behaviour or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.The investigation also considered whether the design limitation of the corelock mechanism could be a potential contributing factor.However, further biomechanical testing identified that the product performance is in an acceptable range in comparison with legally marketed similar devices.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available.

• Brand Name: ANN, BLUNT TIP SCREW, 4X44MM
• Common Device Name: AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14601598
• Report Number: 0009613350-2022-00318
• Device Sequence Number: 5064934
• Product Code: HSB
• UDI-Device Identifier: 00889024505469
• UDI-Public: (01)00889024505469(17)260630(10)3076805
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-044-40
• Device Lot Number: 3076805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown